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NCT01430403 · ClinicalTrials.gov registry record · Phase 4
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 478
- Enrollment target
NCT01430403: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01430403 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 478 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01430403, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 478 participants
- Enrollment target
Study Summary
The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.
Primary Outcome
Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednis
Interventions
- BIOLOGICAL Omalizumab
- BIOLOGICAL Placebo omalizumab
- DRUG Inhaled Corticosteroid Boost Therapy (ICS)
- BIOLOGICAL Placebo fluticasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT01430403 record still lists
NCT01430403 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Omalizumab is the first listed.
NCT01430403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01430403 about?
NCT01430403 is a clinical study titled "Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations". The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to t...
What is the current status of trial NCT01430403?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 478 participants. The study started on 2011-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01430403?
The interventions under investigation include: Omalizumab (BIOLOGICAL), Placebo omalizumab (BIOLOGICAL), Inhaled Corticosteroid Boost Therapy (ICS) (DRUG), Placebo fluticasone (BIOLOGICAL).
Who is sponsoring clinical trial NCT01430403?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01430403's enrollment target sits among peer trials
478 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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